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Review 2: "SARS-CoV-2 serological tests can generate false positive results for samples from patients with chronic inflammatory diseases"

This potentially reliable study suggests certain serologic assays for viral antibodies may have increased false-positives in patients with chronic inflammatory diseases. Additional independent verification in well-defined cohorts is needed.

Published onJan 15, 2021
Review 2: "SARS-CoV-2 serological tests can generate false positive results for samples from patients with chronic inflammatory diseases"
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key-enterThis Pub is a Review of
SARS-CoV-2 serological tests can generate false positive results for samples from patients with chronic inflammatory diseases
Description

Abstract Objectives Patients with chronic inflammatory diseases are often treated with immunosuppressants and therefore are of particular concern during the SARS-CoV-2 pandemic. Serological tests will improve our understanding of the infection and immunity in this population, unless the tests give false positive results. The aim of this study was to evaluate the specificity of SARS-Cov-2 serological assays with samples from patients with chronic inflammatory diseases collected before April 2019, thus defined as negative.Methods Samples from patients with multiple sclerosis (MS, n=10), rheumatoid arthritis (RA, n=47) with or without rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibodies (anti-CCP2) and RF +/- systemic lupus erythematosus (SLE, n=10), were tested with 17 commercially available lateral flow assays (LFA), two ELISA kits and one in-house developed multiplex bead-based assay.Results Six LFA and the in-house IgG assay gave the correct negative results for all samples. However, the majority of assays (n=13), gave false positive signal with samples from patients with RA and SLE. This was most notable in RF positive RA samples. MS samples did not give any false positive in any of the assays.Conclusion The majority of the verified serological assays were sensitive to interfering antibodies in samples from patients with chronic inflammatory diseases and therefore may have poor specificity in this context. For these patients, the risk of false positivity should be considered when interpreting results of the SARS-CoV-2 serological assays.

RR:C19 Evidence Scale rating by reviewer:

  • Reliable. The main study claims are generally justified by its methods and data. The results and conclusions are likely to be similar to the hypothetical ideal study. There are some minor caveats or limitations, but they would/do not change the major claims of the study. The study provides sufficient strength of evidence on its own that its main claims should be considered actionable, with some room for future revision.

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Review:

The findings are interesting to indicate new ways to validate future tests, therefore, interesting to learn more about COVID19 and its implications for society. The work uses current references for the debate, bringing a broad and well-founded discussion. I missed more comments regarding the study's limitations, however, as it is a primary research article on the subject, its limited number of tests is acceptable. A quick check for spelling and general errors is required.

The RR:C19 Strength of Evidence scale

Claims are very well-supported by the data and methods used. Decision-makers should consider the claims in this study actionable with limitations based on the methods and data.

Should this preprint be published?

Accept manuscript without modification.

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